The U.S. Food and Drug Administration (FDA) has approved expanding the label of efgartigimod alfa-fcab to include adult patients with any serotype of generalized myasthenia gravis (MG), according to a recent press release from the company that makes the drug, argenx SE.
Efgartigimod alfa-fcab (marketed as Vyvgart) is a monoclonal antibody that is already FDA-approved for patients with generalized MG who are acetylcholine receptor (AChR)-antibody positive. While most people with generalized MG are AChR-antibody positive, about 20% of patients have other serotypes. For those patients, figuring out what’s wrong and finding the right treatment has been much harder.
The new approval means patients with MuSK antibodies, LRP4 antibodies or who are triple seronegative can now be prescribed efgartigimod and efgartigimod alfa and hyaluronidase-qvfc (sold as Vyvgart Hytrulo). These therapies are now the first and only treatments approved for all adult patients with generalized MG — no matter whether they have AChR antibodies or not.
“For too long, gMG patients who do not have detectable AChR-Ab have been left behind, feeling disengaged and excluded from receiving treatments that specifically treat their disease, which has led to patients experiencing a higher burden of suffering,” said Allison Foss, executive director of the Myasthenia Gravis Association. “This approval validates that gMG patients without AChR-Ab can benefit from a targeted treatment, bringing a sense of hope to thousands in our community.”
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Efgartigimod works by lowering the amount of harmful antibodies in the blood that cause generalized MG symptoms. Vyvgart Hytrulo is a version of the same medicine that can be given as a shot just under the skin, instead of through an intravenous (IV) infusion.
The FDA’s decision was based on results from a large study called the ADAPT SERON trial. It was the biggest study ever done on generalized MG patients who don’t have the AChR-Ab protein. The study found that patients who took efgartigimod got better quickly and stayed better over time. Their symptoms improved in areas like speaking, seeing, moving and swallowing. The medicine was also found to be safe and well-tolerated across all patient types.
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